Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
NCT05511844 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-07-04
Summary
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
Conditions
- HER2-positive Breast Cancer
- HER-2 Protein Overexpression
- HER-2 Gene Amplification
- HER2 Gene Mutation
Interventions
- DRUG
-
ORM-5029
Intravenous infusion
Sponsors & Collaborators
-
Orum Therapeutics USA, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-03
- Primary Completion
- 2025-06-02
- Completion
- 2025-06-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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